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Highlights

  • COAST Phase 3 trial did not meet primary endpoint of change in visual acuity from baseline
  • Sozinibercept combination therapy showed no significant improvement over aflibercept monotherapy
  • Opthea reviews Development Funding Agreement obligations amid trial results

Opthea Limited (NASDAQ:OPT), a clinical-stage biopharmaceutical company, has announced the results of its global Phase 3 COAST (Combination OPT-302 with Aflibercept Study) trial, which evaluated the combination therapy of sozinibercept and aflibercept for the treatment of wet age-related macular degeneration (wet AMD). The trial did not meet its primary endpoint of a meaningful change in best corrected visual acuity (BCVA) after 52 weeks.

In the COAST trial, patients with minimally classic and occult lesions who received the sozinibercept combination therapy at either a 4-week or 8-week dosing regimen showed a mean change in BCVA of 13.2 letters from baseline, compared to 13.8 letters with aflibercept monotherapy. In the overall study population, the combination therapy achieved mean BCVA improvements of 13.5 and 12.8 letters for the 4-week and 8-week regimens, respectively, which were comparable to the 13.7 letters improvement seen with aflibercept monotherapy. The p-values for these comparisons indicated no statistically significant difference.

Despite the negative outcome of the primary endpoint, sozinibercept combination therapy was generally well tolerated, and no significant safety concerns arose. However, there was no numerical difference observed in the key secondary endpoints.

Following the disappointing trial results, Opthea is reviewing the data for accuracy and integrity and has not identified any anomalies that would alter the company’s assessment. Additionally, Opthea is evaluating its obligations under its Development Funding Agreement (DFA) with investors. Depending on the circumstances, the company may be required to make substantial payments to DFA investors, which could significantly impact its solvency. The company is actively discussing possible options with the DFA investors to determine the best course of action for the company’s clinical program and future.